Urinalysis from Roche What else

Transcription

1 Urinalysis from Roche What else

2 Ascorbic acid - Vitamin C Healthy, powerful and interfering Be attentive Consider that laboratories testing urine samples regularly found high amounts of ascorbic acid ( 400 mg/l) in a significant proportion of a routinely tested population 1 Find the answer Do not miss the opportunity to detect symptoms of a potentially serious disease. Use ascorbic acid resistant urine test strips and detect immediately reliable and precise results Identify the problem Recognize the potential of ascorbic acid interference on urine test strips based on the peroxidase redox indicator test principle Solve the problem Use iodate impregnated components to minimize the influence of ascorbic acid on blood and glucose test pads even under high levels of ascorbic acid (up to 750 mg/l) Diminish adulterating influences Eliminate the interference of ascorbic acid in urine test strips and prevent false negative results, which necessitate a retesting of patients or a more expensive microscopic examination Feel safe Avoid potentially serious and costly consequences of false negative results for doctor and patient using iodate impregnated urine strips such as applied in Combur-Test

3 Ascorbic acid - Vitamin C Specifications Definition Water soluble vitamin Chemical name: 2-oxo-L-threo-hexono-1,4-lactone-2,3-enediol A six-carbon compound, structurally related to glucose Characteristics Average half life: days 2 Elimination via the urine Renal threshold: plasma ascorbate concentrations of about mg/dl corresponding to 60 mg doses per day 3-6 Average body tissue of an adult stores g presumably maintained by taking mg per day 3-5,7,8 RDA* 90 mg per day for an adult male (set by the US Food and Nutrition Board in 2000) 9 Ingestion of 60 mg/day prevents the development of scurvy for days with a diet lacking vitamin C 3,4,7,8 Sources Natural: fresh fruits and vegetables, e.g., oranges, lemons, grapefruits, watermelons, papayas, strawberries, green leafy vegetables, tomatoes, broccoli, etc. Synthetic: used in vitamin preparation, as preservative and antioxidant (e.g., E300, E301, E302, E303, E304), discoloration inhibitor, supplement in tablets, food additive Consumption The most frequently used vitamin supplement in the world 10 Worldwide annual demand in 1995 was evaluated at tons 11 Functions Required for many metabolic functions in humans and cofactor for lots of metabolic reactions Potent reducing agent playing an important role in the antioxidant defense system, immune competence, and in strengthening resistance to infection Vitamin C prevents DNA mutations and might be important in treating certain cancers, heart disease and other chronic diseases Interference Ascorbic acid has the ability to prevent oxidization of indicator substances in urine test strips e.g. in peroxidase redox indicator test principle. Interference can be removed using iodate test components such as applied in Combur-Test * Recommended daily allowance References 1. Nagel, D., Seiler, D., Hohenberger, E.F., Ziegler, M. (2006). Investigations of ascorbic acid interference in urine test strips. Clin Lab; 52: Hellman, L., Burns, J.J. (1958). Metabolism of L-ascorbic acid-1-c14 in man. J Biol Chem; 230: Baker, E.M., Hodges, R.E., Hood, J., Sauberlich, H.E., March, S.C. (1969). Metabolism of ascorbic-1-14c acid in experimental human scurvy. Am J Clin Nutr; 22: Baker, E.M., Hodges, R.E., Hood, J., Sauberlich, H.E., March, S.C., Canham, J.E. (1971). Metabolism of 14C- and 3H-labeled L-ascorbic acid in human scurvy. Am J Clin Nutr; 24: Kallner, A., Hartmann, D., Hornig, D. (1979). Steady-state turnover and body pool of ascorbic acid in man. Am J Clin Nutr; 32: Pietrzik, K., Loew, D., Golly, I. (2008). Vitamin C. In: Handbuch Vitamine. Für Prophylaxe, Therapie und Beratung. Munich: Urban & Fischer, Elsevier GmbH; Hodges, R.E., Baker, E.M., Hood, J., Sauberlich, H.E., March, S.C. (1969). Experimental scurvy in man. Am J Clin Nutr; 22: Hodges, R.E., Hood, J., Canham, J.E., Sauberlich, H.E., Baker, E.M. (1971). Clinical manifestations of ascorbic acid deficiency in man. Am J Clin Nutr; 24: Food and Nutrition Board IoM, National Academies. (2008). Dietary Reference Intakes: Recommended Intakes for Individuals, Vitamins. Washington D.C. 10. Naidu, K.A. (2003). Vitamin C in human health and disease is still a mystery? An overview. Nutr J; 2: Elvers, B., Hawkinds, S. (1996). Ullmann s Encyclopedia of Industrial Chemistry. COBAS, LIFE NEEDS ANSWERS, COMBUR-TEST and URISYS are trademarks of Roche Roche Roche Diagnostics Ltd. CH-6343 Rotkreuz Switzerland

4 cobas u 411 analyzer Fast, flexible and competent Considered for workloads of approximately 80 samples per day and what it takes to further optimize workflow Define your own pace Impact workload with flexibility of continuous test strip loading Judge at one glance Differentiate quickly normal and abnormal results or samples to sieve for microscopy examination with availability of userdefinable flags Consolidate your analysis Work parallel on the cobas u 411 analyzer and its sediment terminal as a result of a consolidated work- and dataflow for strip analysis and microscopy. Ease documentation and improve overview of patient records with single print-out for strip and microscopic information Ensure comparability Standardize microscopy result reporting with selection of pre-defined result ranges on the sediment terminal Ease workload Reduce manual work with sample identification via barcode reader or download from host, electronic transfer of sediment work list and printable QC results Secure your investment Stay easily up-to-date with simplified software upload via USB slot

5 cobas u 411 analyzer Technical specifications Instrument System Semi-automated urine test strip analyzer Type Measuring system Throughput Memory User interface Printer Certificates Physical dimensions Weight Reflectance photometer Wave lengths: 470 nm, 555 nm, 620 nm Approx. 600 test strips/h 1000 sample results, 300 control results (3 levels) LCD touch screen (90x120 mm) Thermal printer CE, UL, CB, CUL Width: 42.5 cm Depth: 34.0 cm Height: 26.0 cm Approx. 12 kg Strips* Test strips Combur 10 Test M Parameters Calibration Specific gravity, ph, leukocytes, nitrite, protein, glucose, ketones, urobilinogen, bilirubin, blood (erythrocytes/ hemoglobin), color Control-Test M calibration strip Connectivity System interfaces Serial interfaces to barcode reader, sediment terminal and PC/ Host; USB Slot Host protocols Sample identification ASTM + and Urisys 2400 ASTM Sample ID via manual entry, barcode reader or download from host Accessories Type Barcode reader, Sediment Terminal Supported barcode types Code 39, Code 128, NW 7 (Codabar), ITF (Interleaved 2 of 5) * Combur Test strips are marketed under Chemstrip in United States and Canada. COBAS, COBAS U, LIFE NEEDS ANSWERS, COMBUR-TEST and URISYS are trademarks of Roche Roche Roche Diagnostics Ltd. CH-6343 Rotkreuz Switzerland

6 Combur-Test strip technology Accurate, safe and protective Nylon mesh Carrier foil Reagent paper Absorbent paper Be confident with the results Count on protection and stable performance since sensitive areas are protected against contact, contamination or abrasion with the application of a nylon mesh Detect UTI for sure Prevent false leukocyte results through improved reagent stability in the leukocyte test pad Have no doubts Benefit from a uniform color development of test pads due to the usage of a fine porous nylon mesh Don t worry with ascorbic acid Avoid patient revisits just because of vitamin C interference with iodate impregnated components protecting blood and glucose detection even from high levels of ascorbic acid Believe in what you see Be convinced of your diagnosis. Identify even slight pathological changes in the urine as a result of high sensitivity and clear color changes in the test area Rely on quality Provide a basis for standardized diagnostic procedures with the application of high-quality urine test strips based on years of research and development

7 Combur-Test strip technology Specifications Nylon mesh fixing of components unique sealing technology Stable reaction colors Sturdy plastic carrier foil Iodate impregnated component No interference with glue components Avoidance of contamination by protective function Uniform liquid penetration and color development No run over of reaction color Synchronized reaction time All in 60 seconds No splashing of urine, hygienic strip reading Absorbent paper Protects blood and glucose test areas efficiently from ascorbic acid interference and false-negative results by oxidization even at high concentrations of vitamin C. When five common 10 parameter urine test strips are compared, Combur-Test strip showed the highest resistance to ascorbic acid interference at higher hemoglobin or glucose concentrations 1 : Ascorbic acid interference in routine analysis Hemoglobin (Target value of mg/dl = 25 Ery/µL) Glucose (Target value of 300 mg/dl) Hemoglobin [Ery/µL] Combur 10 Other Brands Target value Combur 10 Other Brands Target value 500 Combur10 test UX from Roche Combur10 test UX from Roche Glucose [mg/dl] Ascorbic acid [mg/l] Ascorbic acid [mg/l] Additional diazonium salt impregnated mesh Absorbent paper Low test detection limits Reliable visual evaluation At a hemoglobin concentration of mg/dl, Combur-Test strips were the only brand to register a correct analysis with ascorbic acid levels as high as 400 mg/l 1 Improves reagent stability in the leukocyte test pad At a glucose concentration of 300 mg/l, Combur- Test strips were the only brand to show consistently accurate results, even at an ascorbic acid level of 1000 mg/l 1 Prevents chemical interference High sensitivity and specificity With no ascorbic acid present, only three out of five tests were able to detect pathologically relevant low hemoglobin and glucose concentrations of 0.03 mg/dl and 50 mg/dl, respectively 1 Colorfast printing colors on the label Reading of all test pads at once at a consistent reading time References 1. Nagel, D., Seiler, D., Hohenberger, E.F., Ziegler, M. (2006). Investigations of ascorbic acid interference in urine test strips. Clin Lab; 52: COBAS, LIFE NEEDS ANSWERS and COMBUR-TEST are trademarks of Roche Roche Roche Diagnostics Ltd. CH-6343 Rotkreuz Switzerland

8 Combur-Test strips* Precise, secure and easy A quality choice for professional use. Be on the safe side Be independent from interferences of glued components as a result of an unique sealing technology Find an immediate answer to ascorbic acid Avoid retesting and prevent false-negative results in glucose and blood even under high levels of ascorbic acid (up to 750 mg/l) with the application of an iodate impregnated mesh layer Be accurate Detect even low concentrations of erythrocytes/hemoglobin (5-10 Ery/μL) Results you can trust Reduce risk of false results through compensation of strong intrinsic urine coloration with the availability of a color compensation pad ** Be specific Stop test area colors from running through an absorbent paper Choose the easy way Ease analysis of results with a consistent reading time of 60 seconds for all parameters. Benefit from advanced and hygienic strip handling with possibility of reading tip down

9 Combur-Test strips* Technical specifications Parameter combinations Parameters Name SG ph LEU NIT PRO GLU KET UBG BIL BL Combur 2 Test Combur 3 Test Combur 3 Test E Combur 4 Test Combur 5 Test Combur 6 Test Combur 7 Test Combur 9 Test Combur 10 Test Local availability might differ, please check with your local representative Test construction Composition Reagent paper and underlying absorbent paper are sealed with a thin porous nylon mesh and fixed to a carrier foil Nylon mesh features Protection from strip contamination. Homogenous liquid distribution and uniform color development. Prevention from falsification of the color by glue Practical detection limit Detection limit is made such that even slight pathological changes in the urine are made visible by a clear color change in the test area Vial construction Composition Protection of test strips from atmospheric humidity with drying agent filled cap Color Scale Special colorfast printing colors on the vial label allow easy and reliable evaluation of the resultsy * Combur Test strips are marketed under Chemstrip in United States and Canada. ** Only available for instrument tests COBAS, LIFE NEEDS ANSWERS and COMBUR-TEST are trademarks of Roche Roche Roche Diagnostics Ltd. CH-6343 Rotkreuz Switzerland